On April 6, the Senate Committee on Health, Education, Labor and Pensions moved for the approval of five bills on biomedical research, Precision Medicine Initiative, and drug development. Collectively, these represent the last part of the Senate’s Innovation for Healthy Americans initiative, which was originally brought out as a single bill, but now contains 19 separate bills. The package is meant to go hand-in-hand with the passage of the 21st Century Cures Act. Instead of voting on the House’s bill, the Senate has chosen to instead develop a version that can pass the full chamber.
The outstanding bills are now in the pipeline, awaiting resolution of a dispute over mandatory funding for the NIH. The stalling also stems from an issue over reforms to the FDA approval process. Some senators are apprehensive about the coverage of bill funding to the FDA, as far as it needs to implement the proposed reforms. Others are looking to get the NIH funding into mandatory status, instead of being discretionary. Also, a few say that funding is not subject to changes in the annual appropriations process.
The HELP committee had previously approved legislation on medical records compliance, treatment of rare diseases, medical devices, and young researchers, all in February. In March, it reported out legislation on adding ZIKA vaccine eligibility, and the development of medical countermeasures against bioterrorism, as having passed the Senate on March 17, after approval by a voice vote In the House on April 12.
Majority Leader in the Senate, Mitch McConnell, promised that the bill would have floor time after HELP committee finishes its work on the bill and sends it in for a vote. But any legislation entering this year has little time, with both Chambers having many priorities to consider. The election in November means they will be out of Washington from mid July, and sessions right after the elections are usually unproductive. This is why the next couple of months are the best time for any meaningful work to be carried out.
If this version of the bill manages to pass the Senate, the two Chambers will have to find common ground between their respective innovations bills using a conferencing process.